483
Generation Next FertilityGeneration Next Fertility – FDA 483, May 25, 2022
Record Details
Generation Next Fertility in New York, NY, received a Form 483 for deficiencies in their human cells, tissues, and cellular and tissue-based products (HCT/P) donor screening and testing processes. The firm failed to properly determine donor eligibility based on screening results and lacked adequate procedures for donor testing and screening. These issues indicate a moderate severity regarding donor safety and compliance with HCT/P regulations.
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ID · a3b172aa-5999-4490-8e09-12f3c3971b09
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